ASSESSING THE CLINICAL RELEVANCE AND RISK MINIMIZATION OF ANTIBODIES TO BIOLOGICS IN JUVENILE IDIOPATHIC ARTHRITIS (JIA) (ABIRISK) - PRELIMINARY RESULTS

Martina Finetti; Gabriella Giancane; Francesca Bagnasco; Pavla Dolezalova; Elena Tsitsami; Maria Trachana; Isabelle Koné-Paut; Despoina Maritsi; Erkan Demirkaya; Giovanni Filocamo; Pierre Quartier; Olga Vougiouka; Rolando Cimaz; Rebecca Nicolai; Helga Sanner; Alina L. Boteanu; Alma N. Olivieri; Elzbieta Smolewska; Elisabeth Solau Gervais; Maria C. Maggio; Valda Stanevicha; Seza Ozen; Michael Hofer; Mihaela Spirchez; Maria G. Magnolia; Veronika Vargova; Denis Mulleman; Florian Deisenhammer; Marc Pallardy; Xavier Mariette; Laura Carenini; Mariangela Rinaldi; Alberto Martini; Nicolino Ruperto

ASSESSING THE CLINICAL RELEVANCE AND RISK MINIMIZATION OF ANTIBODIES TO BIOLOGICS IN JUVENILE IDIOPATHIC ARTHRITIS (JIA) (ABIRISK) - PRELIMINARY RESULTS

Martina Finetti, Gabriella Giancane, Francesca Bagnasco, Pavla Dolezalova, Elena Tsitsami, Maria Trachana, Isabelle Koné-Paut, Despoina Maritsi, Erkan Demirkaya, Giovanni Filocamo, Pierre Quartier, Olga Vougiouka, Rolando Cimaz, Rebecca Nicolai, Helga Sanner, Alina L. Boteanu, Alma N. Olivieri, Elzbieta Smolewska, Elisabeth Solau Gervais, Maria C. MaggioValda Stanevicha, Seza Ozen, Michael Hofer, Mihaela Spirchez, Maria G. Magnolia, Veronika Vargova, Denis Mulleman, Florian Deisenhammer, Marc Pallardy, Xavier Mariette, Laura Carenini, Mariangela Rinaldi, Alberto Martini, Nicolino Ruperto

Research output: Contribution to journal › Meeting Abstract › peer-review

Abstract

Introduction: ABIRISK is a project funded by Innovative Medicine Initiative, with the aim to investigate anti-drug antibody (ADA) formation in the treatment of JIA with biologics (BPs). A major limitation to the use of biologics is the development of ADA that may decrease the efficacy of BPs. Objectives: The aim of this project is to improve the capability to predict biologic immunogenicity in JIA patients. Methods: JIA Patients (by ILAR criteria) followed by 24 PRINTO centres in 12 countries were prospectively enrolled and treated with Etanercept, Adalimumab or Tocilizumab. Patient’s data were obtained from Pharmachild, a pharmacovigilance data registry of JIA patients. For each patient detailed demographic and clinical information were reported; biologic samples were collected for PK and ADA detection before therapy start as well as at periodic visits up to month 18 of follow-up. Disease activity was assessed with Juvenile Arthritis Disease Activity Score-10 (JADAS10) and JIA American College of Rheumatology (JIA ACR) criteria. Results: 148 patients were included in the analysis. Five patients were considered twice because treated with 2 different sequential biologics. Demographic and clinical data by therapy are represented in the table. 54% of the patients were treated with Adalimumab. Disease duration was higher in the group receiving Tocilizumab. Disease activity showed a pattern of improvement over time both globally and for each treatment group (Table 1). Anti-adalimumab and antitocilizumab antibodies were detected respectively in 14 and 3 patients, while no patient developed antibodies anti-etanercept. Conclusion: Preliminary data show a global improvement of disease activity during follow-up period. Analysis of the correlation between drug concentration/ADA development and clinical information will help to determine which patients will respond best to which biologic

Original language	English
Article number	P191
Journal	Pediatric Rheumatology
Volume	16
Issue number	Suppl.2
Publication status	Published - 2018
Externally published	Yes
Event	25th European Paediatric Rheumatology Congress - Lisbon Congress Center (CCL), Lisbon, Portugal Duration: 5 Sept 2018 → 8 Sept 2018 Conference number: 25 https://www.pres.eu/pres2018/

Keywords*

JIA, ABIRISK
Settore MED/38 - Pediatria Generale E Specialistica

Field of Science*

3.2 Clinical medicine

Publication Type*

3.4. Other publications in conference proceedings (including local)

Cite this

Finetti, M., Giancane, G., Bagnasco, F., Dolezalova, P., Tsitsami, E., Trachana, M., Koné-Paut, I., Maritsi, D., Demirkaya, E., Filocamo, G., Quartier, P., Vougiouka, O., Cimaz, R., Nicolai, R., Sanner, H., Boteanu, A. L., Olivieri, A. N., Smolewska, E., Gervais, E. S., ... Ruperto, N. (2018). ASSESSING THE CLINICAL RELEVANCE AND RISK MINIMIZATION OF ANTIBODIES TO BIOLOGICS IN JUVENILE IDIOPATHIC ARTHRITIS (JIA) (ABIRISK) - PRELIMINARY RESULTS. Pediatric Rheumatology, 16(Suppl.2), Article P191.

@article{3b1c6cab8cae44bc95f559fa3d0c41cb,

title = "ASSESSING THE CLINICAL RELEVANCE AND RISK MINIMIZATION OF ANTIBODIES TO BIOLOGICS IN JUVENILE IDIOPATHIC ARTHRITIS (JIA) (ABIRISK) - PRELIMINARY RESULTS",

abstract = "Introduction: ABIRISK is a project funded by Innovative Medicine Initiative, with the aim to investigate anti-drug antibody (ADA) formation in the treatment of JIA with biologics (BPs). A major limitation to the use of biologics is the development of ADA that may decrease the efficacy of BPs. Objectives: The aim of this project is to improve the capability to predict biologic immunogenicity in JIA patients. Methods: JIA Patients (by ILAR criteria) followed by 24 PRINTO centres in 12 countries were prospectively enrolled and treated with Etanercept, Adalimumab or Tocilizumab. Patient{\textquoteright}s data were obtained from Pharmachild, a pharmacovigilance data registry of JIA patients. For each patient detailed demographic and clinical information were reported; biologic samples were collected for PK and ADA detection before therapy start as well as at periodic visits up to month 18 of follow-up. Disease activity was assessed with Juvenile Arthritis Disease Activity Score-10 (JADAS10) and JIA American College of Rheumatology (JIA ACR) criteria. Results: 148 patients were included in the analysis. Five patients were considered twice because treated with 2 different sequential biologics. Demographic and clinical data by therapy are represented in the table. 54% of the patients were treated with Adalimumab. Disease duration was higher in the group receiving Tocilizumab. Disease activity showed a pattern of improvement over time both globally and for each treatment group (Table 1). Anti-adalimumab and antitocilizumab antibodies were detected respectively in 14 and 3 patients, while no patient developed antibodies anti-etanercept. Conclusion: Preliminary data show a global improvement of disease activity during follow-up period. Analysis of the correlation between drug concentration/ADA development and clinical information will help to determine which patients will respond best to which biologic",

keywords = "JIA, ABIRISK, Settore MED/38 - Pediatria Generale E Specialistica",

author = "Martina Finetti and Gabriella Giancane and Francesca Bagnasco and Pavla Dolezalova and Elena Tsitsami and Maria Trachana and Isabelle Kon{\'e}-Paut and Despoina Maritsi and Erkan Demirkaya and Giovanni Filocamo and Pierre Quartier and Olga Vougiouka and Rolando Cimaz and Rebecca Nicolai and Helga Sanner and Boteanu, {Alina L.} and Olivieri, {Alma N.} and Elzbieta Smolewska and Gervais, {Elisabeth Solau} and Maggio, {Maria C.} and Valda Stanevicha and Seza Ozen and Michael Hofer and Mihaela Spirchez and Magnolia, {Maria G.} and Veronika Vargova and Denis Mulleman and Florian Deisenhammer and Marc Pallardy and Xavier Mariette and Laura Carenini and Mariangela Rinaldi and Alberto Martini and Nicolino Ruperto",

year = "2018",

language = "English",

volume = "16",

journal = "Pediatric Rheumatology",

issn = "1546-0096",

publisher = "BioMed Central Ltd.",

number = "Suppl.2",

note = "25th European Paediatric Rheumatology Congress, PReS 2018 ; Conference date: 05-09-2018 Through 08-09-2018",

url = "https://www.pres.eu/pres2018/",

}

Finetti, M, Giancane, G, Bagnasco, F, Dolezalova, P, Tsitsami, E, Trachana, M, Koné-Paut, I, Maritsi, D, Demirkaya, E, Filocamo, G, Quartier, P, Vougiouka, O, Cimaz, R, Nicolai, R, Sanner, H, Boteanu, AL, Olivieri, AN, Smolewska, E, Gervais, ES, Maggio, MC, Stanevicha, V, Ozen, S, Hofer, M, Spirchez, M, Magnolia, MG, Vargova, V, Mulleman, D, Deisenhammer, F, Pallardy, M, Mariette, X, Carenini, L, Rinaldi, M, Martini, A & Ruperto, N 2018, 'ASSESSING THE CLINICAL RELEVANCE AND RISK MINIMIZATION OF ANTIBODIES TO BIOLOGICS IN JUVENILE IDIOPATHIC ARTHRITIS (JIA) (ABIRISK) - PRELIMINARY RESULTS', Pediatric Rheumatology, vol. 16, no. Suppl.2, P191.

TY - JOUR

T1 - ASSESSING THE CLINICAL RELEVANCE AND RISK MINIMIZATION OF ANTIBODIES TO BIOLOGICS IN JUVENILE IDIOPATHIC ARTHRITIS (JIA) (ABIRISK) - PRELIMINARY RESULTS

AU - Finetti, Martina

AU - Giancane, Gabriella

AU - Bagnasco, Francesca

AU - Dolezalova, Pavla

AU - Tsitsami, Elena

AU - Trachana, Maria

AU - Koné-Paut, Isabelle

AU - Maritsi, Despoina

AU - Demirkaya, Erkan

AU - Filocamo, Giovanni

AU - Quartier, Pierre

AU - Vougiouka, Olga

AU - Cimaz, Rolando

AU - Nicolai, Rebecca

AU - Sanner, Helga

AU - Boteanu, Alina L.

AU - Olivieri, Alma N.

AU - Smolewska, Elzbieta

AU - Gervais, Elisabeth Solau

AU - Maggio, Maria C.

AU - Stanevicha, Valda

AU - Ozen, Seza

AU - Hofer, Michael

AU - Spirchez, Mihaela

AU - Magnolia, Maria G.

AU - Vargova, Veronika

AU - Mulleman, Denis

AU - Deisenhammer, Florian

AU - Pallardy, Marc

AU - Mariette, Xavier

AU - Carenini, Laura

AU - Rinaldi, Mariangela

AU - Martini, Alberto

AU - Ruperto, Nicolino

N1 - Conference code: 25

PY - 2018

Y1 - 2018

N2 - Introduction: ABIRISK is a project funded by Innovative Medicine Initiative, with the aim to investigate anti-drug antibody (ADA) formation in the treatment of JIA with biologics (BPs). A major limitation to the use of biologics is the development of ADA that may decrease the efficacy of BPs. Objectives: The aim of this project is to improve the capability to predict biologic immunogenicity in JIA patients. Methods: JIA Patients (by ILAR criteria) followed by 24 PRINTO centres in 12 countries were prospectively enrolled and treated with Etanercept, Adalimumab or Tocilizumab. Patient’s data were obtained from Pharmachild, a pharmacovigilance data registry of JIA patients. For each patient detailed demographic and clinical information were reported; biologic samples were collected for PK and ADA detection before therapy start as well as at periodic visits up to month 18 of follow-up. Disease activity was assessed with Juvenile Arthritis Disease Activity Score-10 (JADAS10) and JIA American College of Rheumatology (JIA ACR) criteria. Results: 148 patients were included in the analysis. Five patients were considered twice because treated with 2 different sequential biologics. Demographic and clinical data by therapy are represented in the table. 54% of the patients were treated with Adalimumab. Disease duration was higher in the group receiving Tocilizumab. Disease activity showed a pattern of improvement over time both globally and for each treatment group (Table 1). Anti-adalimumab and antitocilizumab antibodies were detected respectively in 14 and 3 patients, while no patient developed antibodies anti-etanercept. Conclusion: Preliminary data show a global improvement of disease activity during follow-up period. Analysis of the correlation between drug concentration/ADA development and clinical information will help to determine which patients will respond best to which biologic

AB - Introduction: ABIRISK is a project funded by Innovative Medicine Initiative, with the aim to investigate anti-drug antibody (ADA) formation in the treatment of JIA with biologics (BPs). A major limitation to the use of biologics is the development of ADA that may decrease the efficacy of BPs. Objectives: The aim of this project is to improve the capability to predict biologic immunogenicity in JIA patients. Methods: JIA Patients (by ILAR criteria) followed by 24 PRINTO centres in 12 countries were prospectively enrolled and treated with Etanercept, Adalimumab or Tocilizumab. Patient’s data were obtained from Pharmachild, a pharmacovigilance data registry of JIA patients. For each patient detailed demographic and clinical information were reported; biologic samples were collected for PK and ADA detection before therapy start as well as at periodic visits up to month 18 of follow-up. Disease activity was assessed with Juvenile Arthritis Disease Activity Score-10 (JADAS10) and JIA American College of Rheumatology (JIA ACR) criteria. Results: 148 patients were included in the analysis. Five patients were considered twice because treated with 2 different sequential biologics. Demographic and clinical data by therapy are represented in the table. 54% of the patients were treated with Adalimumab. Disease duration was higher in the group receiving Tocilizumab. Disease activity showed a pattern of improvement over time both globally and for each treatment group (Table 1). Anti-adalimumab and antitocilizumab antibodies were detected respectively in 14 and 3 patients, while no patient developed antibodies anti-etanercept. Conclusion: Preliminary data show a global improvement of disease activity during follow-up period. Analysis of the correlation between drug concentration/ADA development and clinical information will help to determine which patients will respond best to which biologic

KW - JIA, ABIRISK

KW - Settore MED/38 - Pediatria Generale E Specialistica

M3 - Meeting Abstract

SN - 1546-0096

VL - 16

JO - Pediatric Rheumatology

JF - Pediatric Rheumatology

IS - Suppl.2

M1 - P191

T2 - 25th European Paediatric Rheumatology Congress

Y2 - 5 September 2018 through 8 September 2018

ER -

ASSESSING THE CLINICAL RELEVANCE AND RISK MINIMIZATION OF ANTIBODIES TO BIOLOGICS IN JUVENILE IDIOPATHIC ARTHRITIS (JIA) (ABIRISK) - PRELIMINARY RESULTS

Abstract

Keywords*

Field of Science*

Publication Type*

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